Following convincing results from the Phase III ADAURA study, the indication for osimertinib was expanded in Switzerland. Thus, the drug may now also be used for adjuvant therapy in early-stage non-small cell lung cancer (NSCLC) with EGRF mutation.
Until now, the irreversible EGFR tyrosine kinase inhibitor (TKI) osimertinib (Tagrisso®) was only approved in Switzerland for the treatment of locally advanced or metastatic NSCLC. Here, it is used for the first-line treatment of patients with EGFR exon 19 deletions or exon 21 substitution mutations, on the one hand, and for the therapy of tumors with EGFR T790 mutation that show progression under another EGFR TKI, on the other hand. New study results have now led to an extension of these indications to EGFR-mutated early-stage NSCLC after complete tumor resection.
In the international phase III ADAURA trial, adjuvant treatment with osimertinib reduced the risk of relapse by 83% in patients with stage II and IIIA disease [1]. An 80% reduction in the risk of recurrence was observed in the entire study population, which included 682 affected individuals with stage IB to IIIA tumors. After two years, 89% of patients treated with osimertinib were still alive and disease-free – compared to 52% on placebo. All study participants had received prior complete tumor resection and adjuvant chemotherapy. For three years, or until disease recurrence, the intervention group received one 80-mg tablet of osimertinib daily, and the control group received placebo. Safety and tolerability were consistent with previous data on osimertinib in the ADAURA study.
The newly approved adjuvant use of Tagrisso® could significantly reduce the recurrence rate of EGRF-mutated stage IB to IIIA NSCLC in the future, even outside of clinical trials. This is a worthy goal considering that nearly half of patients with stage IB NSCLC and over 75% of those with initial stage IIIA diagnosis experience disease relapse within five years.
Source: Press release “Tagrisso® (osimertinib) with indication expansion as adjuvant therapy in early-stage non-small cell lung cancer (NSCLC) with EGFR mutation after complete tumor resection”, January 2021, AstraZeneca AG, Baar.
Further reading:
- Wu YL, et al: Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020; 383(18): 1711-1723.
- Technical information Tagrisso® at www.swissmedicinfo.ch, as of January 2021.
InFo ONCOLOGY & HEMATOLOGY 2021; 9(1): 20
